Phase Angle and TyG Index as Markers of Glycaemic Control, Adiposity and Cardiovascular Risk in T1D Adolescents

NCT07021326 | Completed

• 1 other identifier: PA-TYG-T1DM-ADOLESCENTS-2025
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to identify new clinical biomarkers that may improve the follow-up and health outcomes of adolescents with type 1 diabetes. The current clinical practice includes a standard set of measurements for monitoring glycemic control and general health. However, other parameters such as phase angle (obtained through a fast, simple, and painless body composition analysis) might also provide valuable insight into the metabolic status of these patients. This is a cross-sectional observational study that involved a one-time data collection process. Participants underwent a single body composition measurement (10 seconds, using a bioimpedance analyzer). No interventions or follow-up visits were required. Additional data was extracted from medical records, including clinical information (e.g., age of diabetes onset, HbA1c, anthropometrics) and results from recent blood tests. The goal is to determine whether indicators such as the phase angle and triglyceride-glucose (TyG) index could serve as non-invasive tools to assess glycemic control, glycaemic control and cardiovascular risk in adolescents with type 1 diabetes. The study was conducted at two hospitals from Alicante (Spain) and included patients with a confirmed diagnosis of type 1 diabetes who met the inclusion criteria. Participation was entirely voluntary with informed consent obtained from legal guardians. All collected data were anonymized to prevent reidentification and unauthorized access. This research seeks to expand scientific knowledge on diabetes management and support the development of more precise, individualized monitoring tools for young people living with type 1 diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

Adolescent; Metabolic risk; Phase angle; Triglyceride-glucose index; Type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Phase angle

  Measurement of the phase angle using bioelectrical impedance analysis to assess body composition and cellular health in adolescents with type 1 diabetes by using the portable device Biody-Xpert (Aminogram SAS, La Ciotat, France).

  Day 1.

• Triglyceride-glucose index (TyG index)

  Calculation of the TyG index from recent fasting blood samples to evaluate insulin resistance and glycaemic control. The TyG index was calculated as Ln\[fasting triglycerides (mg/dl) x fasting glucose (mg/dl)/2\].

  Day 1

Secondary Outcomes (15)

• Predictive variable: Fat mass

  Day 1.

• Predictive variable: Skeletal muscle mass

  Day 1.

• Predictive variable: Fat free mass

  Day 1.

• Predictive variable: Lean mass

  Day 1.

• Predictive variable: Total body water

  Day 1.

Study Arms (1)

Unique group: Adolescents with type 1 diabetes mellitus.

Adolescents with type 1 diabetes mellitus who meet the inclusion criteria and participated in a single assessment involving body composition measurement.

Other: there is no intervention

Interventions

there is no intervention OTHER

This is an observational, cross-sectional study with no intervention. Data were collected through a single body composition measurement without any treatment or manipulation. Biochemical, clinical and anthropometric data was collected directly from the patient's clinical records. No intervention was needed.

Unique group: Adolescents with type 1 diabetes mellitus.

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 10 to 19 years with a diagnosis of type 1 diabetes mellitus, with or without continuous glucose monitoring, who attended a routine clinical visit.

You may qualify if:

• Patients with type 1 diabetes mellitus (diagnosed).
• Aged between 10 and 20 years.
• With or without a continuous glucose monitor.

You may not qualify if:

• Not being hospitalized.
• Not being pregnant, in the case of female patients.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• José Miguel Martínez Sanz, PhD

  Universidad de Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 13, 2025
• Study Start: July 21, 2022
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)